Job Description

Develop strategies that align with business imperatives

Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on The Straits Times and Statista's list of Best Employers in Singapore for two consecutive years (2020, 2021).

Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

To support and supervise a group of Microbiologists and coordinate microbiological activities and associated resource needs on day-to-day basis for supporting operations within non-sterile facilities within API, DPI, Pharmaceutical (West and South), and R & D facilities.

Participates in drug product and drug substance analytical development and testing support for all late stage and marketed drug candidates manufactured in Singapore as required.

Support the generation of CMC information for IND amendments and regulatory filings to support marketing approvals as required.

WHAT YOU WILL DO:

Supervise a group of Microbiologists and Analysts.

Lead daily Tier 1 board to provide testing status updates and highlight quality and safety issues for Microbiology Lab.

Support and provide technical information pertaining to microbiological tests to lab management on routine basis.

Review and approve test reports log books, data sheets, documentation that are generated in microbiology lab.

Review SOPs and Protocols with relevant to Microbiology.

Review compendial and other site and corporate policy changes and ensure necessary change control for lab SOPs.

Participate in trouble shooting activities for Utility systems and clean rooms.

Conduct investigations for OOS and OOG results.

Approve/Authorize additional testing/re-testing/re-sampling as appropriate, based on review of test results, Lab investigation Reports & I or cross functional investigation.

Participate in cross functional investigation and other relevant forum to represent Microbiology section.

Coordinate in Method Transfer, Validation studies and Method Qualification Studies.

Participate/co-ordinate in Internal Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities.

Coordinate with Senior Manager in performing periodical appraisal of Microbiologists.

Coordinate with Senior Manager in planning and operation of the Department.

Oversee the Calibration and Preventive Maintenance Programme.

Ensure completion of periodic reviews of SOPs.

Promote Cl culture in the area to ensure sufficient and objective practices.

Develop and manage a competency-based training program for all Microbiology staff and provide coaching and mentoring for staff's personal and professional development.

Participate in SHE, Business Compliance, cGMP and other compliance related matters, where applicable.

Review & approve FECC raise with respect to microbiological impact.

Liaise with other department on planning and related testing.

Liaise with other sites regarding Method transfers, Technology Transfers and other activities.

Liaise with vendors, services engineers/ESPs for equipment validation, calibration and maintenance work. Supervise and oversee Third party Contractors, where applicable

Any other duties as assigned by the Senior Manager/Director.

ACCOUNTABILITIES

Analytical support in commercial supply of drug substances and drug products for Microbiology Laboratories in Singapore site.

Analytical support in development, clinical and other related commercialization activities.

Other relevant activities as described in the Main responsibilities section.

ABOUT YOU:

Bachelor of Science or related engineering degree.

Minimum 7 years relevant experience in the pharmaceutical industry.

Experience with pharmaceutical production process/demonstrated record of investigation analysis/analytical laboratories is highly desirable.

Good knowledge of cGMP, ICH and regulatory guidelines associated with stability, equipment qualification and QA oversight of validation activities.

Good technical understanding and judgment.

Good interpersonal and communication skills.

Team player with ability to work in cross functional teams as well as independently depending on the requirement of task in hand.

Analytical development mindset in research and commercialization activities.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: 1